A Beloit company’s system for producing a crucial medical imaging agent will reduce the risk of shortages and strengthen national security, according to FDA Commissioner Scott Gottlieb.
NorthStar Medical Radioisotopes recently got approval from the FDA for its RadioGenix System. This system is used to extract technetium-99, a commonly used imaging agent, from the company’s non-uranium based molybdenum-99.
“Prior to today, the production process for Tc-99m involved shipping enriched uranium out of the U.S. for irradiation,” Gottlieb said in a recent statement he made “to acknowledge the role the FDA played in the groundbreaking effort to develop a new imaging technology.”
“All of the reactors that produced this source material were located outside of the U.S. creating a complicated, at times uncertain, and potentially risky supply chain,” he said.
Technetium-99 is “the gold standard medical imaging isotope for cardiovascular diseases,” adds Stephen Merrick, who came on as chief operating officer more than two years ago.
“The beauty of Tc-99m is it gives great quality pictures, and leaves very little burden of radioactivity in the patient,” he told WisBusiness.com. “It is an extremely cost-effective form of imaging.”
Tc-99m is used in about two-thirds of of all diagnostic medical isotope procedures in the United States, according to the National Center for Biotechnology Information.
With this approval, NorthStar can now sell both the RadioGenix system and molybdenum-99, or Mo-99, to radiopharmacies. Read the full story here.